Patients’ rights advocates outcry against Modi government passing the buck on costly drugs
The Centre’s affidavit in Kerala High Court, responding to a 24-year-old SMA patient’s petition, has ignored appeals to ...
Pharm Exec8h
Biogen Seeks FDA Approval for a Higher Dosing Regimen of Spinraza for Spinal Muscular Atrophy
Application is supported by results from the DEVOTE study, which suggested that two doses of Spinraza (nusinerse) 50 mg taken ...
SMA11h
US, EU regulators to review higher-dose Spinraza for use in SMA
Regulators in the U.S. and the European Union agreed to review Biogen’s applications for approval of a higher dose Spinraza ...
GEN21h
Généthon, Eukarÿs Partnership Aims to Lower Manufacturing Costs for Gene Therapies
The partners will adapt Eukarÿs' C3P3 engineered enzyme tech to work with adeno-associated virus vectors to boost biomanufacturing yields.
Managed Healthcare Executive1d
FDA and EMA Accepts Applications for New Nusinersen Regimen
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower ...
BioSpace1d
Biogen Trims Research Workforce, Higher-Dose SMA Drug Accepted for Regulatory Review
In a good-news-bad-news week for Biogen, the company will cut an undisclosed number of employees, just as a higher dose of ...
Biogen Says FDA And EMA Accept Applications For Higher Dose Regimen Of Nusinersen In SMA
Biogen Inc. (BIIB) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New ...
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
We are pleased to announce that our applications for the higher dose regimen of nusinersen are now under review in the US and Europe,” said Stephanie Fradette, Pharm.D., Head of the Neuromuscular ...
Biogen Gets U.S., European Reviews of Higher-Dose Spinraza
Biogen said the U.S. Food and Drug Administration has accepted its supplemental new-drug application, while the European Medicines Agency has validated its application, which confirms that the ...
Too Old to Operate1d
Association of SC GM Atrophy With Clinical Disability in SMA
The following is a summary of “Spinal cord gray matter atrophy is associated with disability in spinal muscular atrophy,” ...
360dx2d
MRC Holland Gains IVDR Certification for Spinal Muscular Atrophy Newborn Screening Test
The Amsterdam-based biotech firm said that its melt curve analysis-based test is used as a first-tier genetic screening tool to aid the diagnosis of SMA.
SMA2d
Woman gives birth to healthy child while on Spinraza treatment
A woman with SMA type 3 became pregnant while on Spinraza treatment and gave birth to a healthy child, per a case report.